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Prenate Pixie

Generic Name: prenatal vitamin
Dosage Form: softgel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PRENATE® Pixie 75854-0316

DESCRIPTION: PRENATE® PIXIE is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”.

Supplement Facts
Serving Size: 1 Softgel
Amount per Serving: % Daily
Value
% Daily
Value
(Pregnant &
Lactating
Women)
Vitamin C (as ascorbic acid) 30 mg 50% 50%
Biotin 75 mcg 25% 25%
Vitamin D3
(as cholecalciferol)
500 IU 125% 125%
Vitamin B12
(as cyanocobalamin)
13 mcg 217% 163%
Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg) 1 mg 250% 125%
Iron (as ferrous asparto glycinate) Sumalate® 10 mg 56% 56%
Iodine (as potassium iodide) 150 mcg 100% 100%
Vitamin B6 (as pyridoxine HCl) 5 mg 250% 200%
Vitamin E
(as dl-alpha tocopheryl acetate)
10 IU 33% 33%
Docosahexaenoic acid (DHA) 200 mg
Blueberry extract
(vaccinium spp.)
5 mg

† Daily Value (DV) not established.

PRENATE® PIXIE contains fish oil and soy.

OTHER INGREDIENTS: Bovine gelatin, glycerin, yellow beeswax, soy lecithin, vegetable shortening, purified water, titanium dioxide, FD&C Red #40, caramel and FD&C Blue #1.

INDICATIONS: PRENATE® PIXIE is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS: PRENATE® PIXIE is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

PRENATE®Pixie is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION

Rev. 1014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 softgel container image

75854-0316-30

Prenate® pixie

Robust Rx Prenatal Vitamin with
11 concentrated nutrients and minerals
in a tiny softgel package

GLUTEN FREE

Rx Only

Prenatal Supplement

30 Softgels

Avion
PHARMACUETICALS

Prenate Pixie 
ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-316
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
BIOTIN (BIOTIN) BIOTIN 75 ug
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 500 [iU]
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 10 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 5 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 200 mg
BLUEBERRY (BLUEBERRY) BLUEBERRY 5 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 600 ug
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
YELLOW WAX  
LECITHIN, SOYBEAN  
CORN OIL  
WATER  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
CARAMEL  
FD&C BLUE NO. 1  
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 22mm
Flavor Imprint Code PIX
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-316-30 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/14/2014
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 04/2015
 
Avion Pharmaceuticals, LLC



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